A Randomized Controlled Pilot Trial of Mesalazine in Patients With Irritable Bowel Syndrome - Full Text View

Sponsors and Collaborators:	SOFAR S.p.A. St. Orsola Hospital
Information provided by:	SOFAR S.p.A.
ClinicalTrials.gov Identifier:	NCT00774007

Purpose

Emerging evidence indicates the presence of low-grade mucosal inflammation and its pathogenetic role in IBS. The aim of this pilot study is to provide that mesalazine treatment of IBS patients reduces low grade colonic inflammation.

Condition	Intervention	Phase
Irritable Bowel Syndrome	Drug: mesalazine Drug: placebo	Phase II Phase III

Drug Information available for: Mesalamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Mesalazine on Low Grade Mucosal Inflammation in Irritable Bowel Syndrome. A Pilot Double Blind Placebo Controlled Study.

Further study details as provided by SOFAR S.p.A.:

Primary Outcome Measures:

The primary endpoint in the study was to assess the effect of mesalazine treatment on total number of mucosal immune cells in the colonic mucosa of patients with IBS. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Effect of mesalazine on: 1) mucosal immune cell subsets; 2) inflammatory mediator release from mucosal biopsies; 3) symptom relief, as detected by means of visual analogue scales. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	20
Study Start Date:	September 2004
Study Completion Date:	November 2005
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator Placebo	Drug: placebo
Mesalazine: Active Comparator mesalazine 800 mg t.i.d.	Drug: mesalazine

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

IBS patients (both males and females) with positive diagnosis based on Rome II criteria
age ≥ 18 years
Patients capable of conforming to the study protocol;
Patients who have given their free and informed consent

Exclusion Criteria:

Patients with ascertained Inflammatory Bowel Diseases (Crohn disease, Diverticular disease, Ulcerative colitis, Infectious colitis, Ischemic colitis, microscopic colitis)
Patients with ascertained food intolerance/allergy
Patients with active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable)
Presence of major abdominal surgeries
Ascertained hypersensitivity to the salicylates
Positive faecal culture for bacterial, or parasitic pathogens
Patients with history of clinically significant renal (creatinine ≥ 2.0 mg/dL or ≥177 μmol/L), hepatic (AST or ALT greater than three times the upper limit of normal range), cardiac, metabolic or haematological disease
Esophageal, gastric or duodenal ulcer within 30 days prior to randomization
Patients with intended or ascertained pregnancy; lactation
Patients who become unable to conform to protocol
Patients who are continuously taking laxatives
Patients in antibiotic therapy during the last month
Patients in current therapy with corticosteroids
Treatment with any investigational drug within the previous 30 days
Treatment with lactulose or with any compound that lowering the colonic pH can prevent the release of the active moiety
Recent history or suspicion of alcohol abuse or drug addiction
Any severe pathology that can interfere with the treatment or the clinical tests of the trial
Previous participation in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774007

Locations

Italy
Department of Internal Medicine & Gastroenterology
Bologna, Italy, 40138

Sponsors and Collaborators

SOFAR S.p.A.

St. Orsola Hospital

Investigators

Principal Investigator:	Giovanni Barbara, MD	University of Bologna
Study Chair:	Roberto Corinaldesi, MD	University of Bologna

More Information

Responsible Party:	Department of Internal Medicine and Gastroenterology, University of Bologna, Bologna, ITALY ( Dr. Giovanni Barbara )
Study ID Numbers:	IBS-01/03
Study First Received:	October 15, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00774007
Health Authority:	Italy: National Institute of Health

Keywords provided by SOFAR S.p.A.:

Irritable bowel syndrome, abdominal pain, abdominal bloating, immune cells, mast cells

Study placed in the following topic categories:

Digestive System Diseases
Mucositis
Mesalamine
Gastrointestinal Diseases
Abdominal Pain
Colonic Diseases

Irritable Bowel Syndrome
Pain
Intestinal Diseases
Colonic Diseases, Functional
Inflammation

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Disease
Physiological Effects of Drugs
Pharmacologic Actions
Pathologic Processes
Analgesics, Non-Narcotic
Sensory System Agents

Syndrome
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009